AQL - Acceptable Quality Level

The acceptable quality level (AQL) is the minimal manufacturing requirement needed for producers to meet before products are rejected. For examination gloves, the FDA sets guidelines that determine this level by enforcing a set of test methods called ASTM. To measure AQL, manufacturers will utilize the water test (ASTM D5151). This test detects any holes on the exam glove which is counted as a defect. The AQL score is calculated by the number of defect gloves per 100 tested. So a AQL requirement of 4.0 means that out of every 100 gloves tested for pinholes, there must be less than 4 gloves that are defective. The lower the AQL score is, the higher quality the medical gloves are. Any batch of exam gloves that are tested higher than FDA's requirement is rejected and can not be sold as a medical glove.

For a long time, the AQL requirement for exam gloves was 4.0 but the FDA changed the requirement to 2.5 for exam gloves and has given all manufacturers of medical exam gloves till 12/29/2008 to adhere to this. Since the majority of exam gloves are now imported, the FDA created more stringent requirements to ensure healthcare professionals are protected.